Ophthalmic Devices in Remote Areas

In April 2020, FDA released the document “Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices during the COVID-19 Public Health Emergency.” https://fda.gov/media/136733/download.

The report outlines FDA’s temporary policy to allow certain modifications to do ophthalmic assessments and the use of monitoring devices to expand to do healthcare in remote areas. FDA intends that this policy will remain in effect only for the duration of the COVID-19 public health emergency.

This change in federal policy will also allow ophthalmic assessments to be done using non-public facing platforms that may not be compliant with HIPAA, such as FaceTime, Zoom, or Skype for telehealth visits. It seems possible that similar policies will be in effect in other specialty areas such as audiology in the near future.

The FDA document covers certain ophthalmic devices that assess or monitor ophthalmic parameters with the potential to connect to a wireless network capable of transmitting data directly to an eye care provider or monitoring entity.

The devices that the FDA document covers also may have the potential to apply algorithms to use to aid in diagnosis, or to determine the severity of a disease or conditions, or help to assess specific parameters remotely during a telemedicine visit from the patient’s home.

In addition, according to the March 2020 issues of the “TATRC Times” the Telemedicine & Advanced Technology Research Center https://www.tatrc.org (TATRC) an office within the Army’s Medical Research Materiel Command (USAMRMC). TATRC performs research on telemedicine, mhealth, medical training systems, and computational biology.

TATRC’s Mobile Health Innovation Center (mHIC) is working on a project called “Forward Operating Base EXpert Telemedicine Resource Utilizing Mobile Application for Trauma”, also known as “FOXTROT”, to improve and extend ophthalmic trauma care to remote environments to help service members.

FOXTROT’s mobile capability incorporates tele-ophthalmology using the mCare app and clinical peripherals tailored to the ophthalmologic needs of the patient and provider. FOXTROT capabilities include triage surveys, image capture, chat, secure messaging, video chat, reports, remote health monitoring, and user management. Service members are now able to experience complete and comprehensive tele-ophthalmology capabilities even in remote areas.


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